Squamous Cell Carcinoma Of The Head
And Neck (SCCHN)

Erbitux is indicated in
combination with platinum-based therapy with 5-FU for the first-line treatment
of patients with recurrent locoregional disease or metastatic squamous cell
carcinoma of the head and neck. [SeeClinical Studies]

Erbitux, as a single agent, is
indicated for the treatment of patients with recurrent or metastatic squamous
cell carcinoma of the head and neck for whom prior platinum-based therapy has
failed. [SeeClinical Studies]

Limitation of Use

DOSAGE AND ADMINISTRATION

Squamous Cell Carcinoma Of The Head And Neck

Erbitux in combination with radiation therapy or in
combination with platinum-based therapy with 5-FU:

The recommended initial dose is 400 mg/m² administered
one week prior to initiation of a course of radiation therapy or on the day of
initiation of platinum-based therapy with 5-FU as a 120-minute intravenous
infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1
hour prior to platinum-based therapy with 5-FU.

Recommended Premedication

Premedicate with an H1 antagonist (eg, 50 mg of
diphenhydramine) intravenously 30–60 minutes prior to the first dose;
premedication should be administered for subsequent Erbitux doses based upon
clinical judgment and presence/severity of prior infusion reactions.

Store vials under refrigeration at 2° C to
8° C (36° F to 46° F). Do not freeze. Increased
particulate formation may occur at temperatures at or below 0° C. This
product contains no preservatives. Preparations of Erbitux in infusion
containers are chemically and physically stable for up to 12 hours at 2°
C to 8° C (36° F to 46° F) and up to 8 hours at controlled
room temperature (20° C to 25° C; 68° F to 77° F).
Discard any remaining solution in the infusion container after 8 hours at
controlled room temperature or after 12 hours at 2° C to 8° C.
Discard any unused portion of the vial.